Description
The Cathay Drug Co., Inc.
DESCRIPTION
FORMULATION
Each 5 mL (1 teaspoonful) of reconstituted suspension contains:
Cefixime ………………………………….. 100 mg
Each mL of reconstituted suspension contains:
Cefixime ………………………………….. 20 mg
PHARMACOLOGY
Mechanism of action
Cefixime acts by binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, resulting in the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins. It is possible that cefixime interferes with an autolysin inhibitor.
Antimicrobial action
Cefixime is bactericidal and is stable to hydrolysis by many beta-lactamases. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to cefixime. It has an expanded spectrum of activity against gram-negative bacteria compared with first and second generation cephalosporins. The antibacterial effect of cefixime results from inhibition of mucopeptide synthesis in the bacterial cell wall.
Cefixime is active in vitro against Streptococcus sp., Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (Branhamella catarrhalis), Escherichia coli, Proteus sp., Haemophilus influenzae, and Neisseria gonorrhae.
Pharmacokinetics
About 40 to 50% of an oral dose is absorbed from the gastrointestinal tract, whether taken before or after meals. The rate of absorption may be decreased in the presence of food. Cefixime is better absorbed from oral suspension than from tablets. The plasma half-life is usually about 3 to 4 hours and may be prolonged when there is renal impairment. About 65% of cefixime is bound to plasma proteins.
Distribution in body tissues and fluids is limited. It crosses the placenta. Relatively high concentrations may be achieved in the bile and urine. About 20% of an oral dose (or 50% of an absorbed dose) is excreted unchanged in the urine within 24 hours. Up to 60% may be eliminated by nonrenal mechanisms; there is no evidence of metabolism but some are probably excreted in the feces from bile. It is not substantially removed via dialysis.
INDICATIONS
Cefixime (TRIOCEF) is used in the treatment of the following infections :
- uncomplicated urinary tract infections
- otitis media
- pharyngitis and tonsillitis
- lower respiratory tract infections (acute bronchitis and acute exacerbations of chronic bronchitis)
- uncomplicated gonorrhea
DOSAGE AND ADMINISTRATION
The usual pediatric dose in children over 6 months and under 50 kg is 8 mg/kg/day. This dosage may be given as a single daily dose or 4 mg/kg may be given every 12 hours. Or as prescribed by the physician.
DIRECTIONS FOR RECONSTITUTION
Cefixime (TRIOCEF) 100 mg/5 mL Granules for Suspension
- To reconstitute: Add 35 mL of water to make a 60 mL suspension.
Prior to reconstitution, tap the bottle several times to loosen granule contents. Add 35 mL of water in TWO PORTIONS to the dry mixture bottle.
- To reconstitute: Add 18 mL of water to make a 30 mL suspension.
Prior to reconstitution, tap the bottle several times to loosen granule contents. Add 18 mL of water in TWO PORTIONS to the dry mixture bottle.
- To reconstitute: Add 5.7 mL of water to make a 10 mL suspension.
Prior to reconstitution, tap the bottle several times to loosen granule contents. Add 5.7 mL of water in TWO PORTIONS to the dry mixture bottle.
Cefixime (TRIOCEF) 20 mg/mL Pediatric Oral Drops
- To reconstitute: Add 7.3 mL of water to make a 10 mL suspension.
Prior to reconstitution, tap the bottle several times to loosen granule contents. Add 7.3 mL of water in TWO PORTIONS to the dry mixture bottle.
CONTRAINDICATIONS
Cefixime (TRIOCEF) is contraindicated to patients with a history of hypersensitivity to penicillins or other cephalosporins.
PRECAUTIONS
Cefixime should be used only for the treatment or prevention of infections after the susceptibility has been strongly suspected or proven, to reduce development of drug-resistant bacteria and maintain the effectiveness of the drug.
Cefixime should be used with caution in patients with a history of allergy, particularly to drugs.
Cefixime may result in overgrowth of nonsusceptible organisms in case of prolonged use,
Cefixime should be used with caution in patients with renal impairment, because serum concentration of cefixime are higher and more prolonged in patients with renal impairment. Thus, dosage and frequency should be monitored.
WARNING
Contains FD&C Yellow No. 5, Tartazine that can cause hypersensitivity reactions.
ADVERSE EFFECTS
Cefixime is generally well tolerated. Most adverse effects reported with cefixime were transient and were usually mild and moderate in severity.
Most frequently reported adverse effects:
GI: Diarrhea, Cefixime should be discontinued if diarrhea is severe.
Rarely adverse effects
Abdominal pain, nausea, dyspepsia, flatulence, acute renal failure, anaphylactic/anaphylactoid reactions, angioedema, BUN increased, candidiasis, creatinine increased, dizziness, drug fever, eosinophilia, erythema multiforme, facial edema, fever, headache, hepatitis, hyperbilirubinemia, jaundice, leucopenia, neutropenia, pruritus, pseudomembranous colitis, prolongation of prothrombin time, rash, seizure, serum sickness-like reaction, Steven-Johnson syndrome, thrombocytopenia, toxic epidermal necrolysis, transaminases increased, urticaria, vaginitis, vomiting.
If any of these adverse events occur, the product should be discontinued and appropriate measures should be taken.
DRUG INTERACTIONS
- Warfarin /other anticoagulants Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is given concomitantly
PREGNANCY AND LACTATION
Category B. There are no controlled data in human pregnancy. Cefixime is only recommended for use during pregnancy when benefit outweighs risk. Caution should be exercised if use is indicated and consideration should be given to temporarily discontinue nursing during therapy with the drug.
AVAILABILITY
Cefixime (TRIOCEF) 100 mg/5 mL Granules for Suspension- Bottle size of 30 mL and 60 mL
Cefixime (TRIOCEF) 20 mg/mL Granules for Suspension (Pediatric Oral drops) – 10 mL (bottle size of 15 mL)
STORAGE
Granules for suspension: Store at temperatures not exceeding 30°C. Protect from light.
Reconstituted suspension: Store for 7 days at temperatures not exceeding 30 °C or 14 days at 2-8°C (Refrigerator_. Keep container tightly closed. Protect from light. Shake well before use.
REFERENCES
Faulkner RD, Bohaychuk W, Lane RA, et al.: Pharmacokinetics of cefixime in the young and elderly. J Antimicrob Chemother 1988; 21(6): 787-794.
http://www.drugs.com
http://www.drugbank.ca/drugs/DB00671
Manufactured by
EL Laboratories, Inc.
109 North Main Ave., Laguna Technopark, Biñan, Laguna
Distributed by
The Cathay Drug Co., Inc.
2/F Vernida I Condominium 120 Amorsolo St. Legaspi Village, Makati City
Date of revision: July 2019
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